The company also announced that the platform has also received CE Mark certification in the European Union, making it the first circumference-reducing product to receive FDA clearance and CE Mark certification to date.
The clearance for thigh circumference reduction was based on a clinical study, which involved 66 patients who observed an average circumferential reduction of .75 inches on the treated thigh. The FDA had previously cleared the Vela platform for cellulite treatment.
“The clearance by the FDA and receipt of the CE mark are key milestones in Syneron’s continuing progress toward development of noninvasive technology for body shaping,” says Shimon Eckhouse, Syneron chairman. “Syneron invested significant resources in this study, developing unique tools which enabled us to reliably prove in a blinded and controlled study the effectiveness of the Vela in thigh circumferential reduction. The choice of thighs for this study rather than other parts of the body gave us a natural control, which is a critical element for such a study."
For more information visit www.syneron.com.
Source: Syneron; Aug 8